continue reading hover preload topbar hover preload widget hover preload

Pharmacovigilance in clinical trials

Categories: Clinical Research, Pharmacovigilance  |   No Comments

Good Clinical Practices sets the principles for drug safety information and news on adverse drug reactions, describing that the clinical study’s sponsor is answerable for the enduring safety evaluation of the novel drugs being explored. Along with this, the Good Clinical Practices must quickly inform all relevant clinicians/ethics committees and the applicable regulatory authority of outcomes that may negatively involve the safety of human volunteers in the trial. This is either because they influence the conduct of the study or may amend the approval verdict by the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) to continue the trial.

A prospective clinical research career!

Categories: Clinical Research, Online Courses  |   No Comments

Contract research, a new business model, that arrived in India many years ago, has shaped itself to provide career opportunities to many individuals.

Several decades ago not a single contract research organization (CRO) was operating in our nation. With the onset of globalization, privatization and the gradual recognition of India at the international stage, a number of CRO’s and pharmaceutical companies began to set up their operations and explore India’s potential. It however took a great deal of time and effort to focus and establish clinical research organizations here.

Differences between Biologics and Pharmaceuticals

Categories: Clinical Research  |   Comments(2)

As pharmaceutical companies are looking forward to expand their territories and expand their offerings in terms of products, the trend is moving towards Biologics. This brings us to our topic of discussion of what is the basic difference between a biologic and a conventional pharmaceutical product?

Digital Signatures in Clinical Trials (Electronic Signatures)

Categories: Clinical Data Management, Good Clinical Practice  |   Comments(2)

A digital signature, also referred to as an electronic signature has been developed using the cryptographic techniques of verifying the originator. Using this technique, the identity of the person who uses a digital signature can be verified. The electronic system uses a complex set of rules and parameters to achieve this.

A digital signature is also known as an e-signature these days. It can be any electronic medium which certifies that the person who has signed the document electronically has read and understood the contents of the documents and is willing to comply with them. In simpler terms, it can be said that an electronic signature can be a synonym to a seal and will be considered legal and verified as the traditional hand written signature.

Clinical Data Management Steps and Processes

Categories: Clinical Data Management  |   No Comments

The Clinical Data Management (CDM) process is like clinical trials, which required a fully planned and integrated scheme from the beginning to the end. The outcome of the process is considered first and the whole process of designing the system is made by considering the final deliverable in mind. The main purpose of an effective clinical data management process is to deliver a valid, error free and statistically relevant database.

Drug Safety Associate

Categories: Clinical Research & Pharmacovigilance, Pharmacovigilance  |   Comments(1)

This short post is an attempt to cover careers pertaining to Pharmacovigilance. One interested in pursuing this career would come across a term called as “Drug Safety Associate”. So who exactly is a Drug Safety Associate and what are the job responsibilities of such a position holder? The roles and responsibilities of a Drug Safety Associate may vary from company to company, but his/her primary responsibilities will be following up Adverse Events Reports, Preparation of Safety Reports as per the guidelines mentioned by the regulatory authority of that particular country, (for example in India it is Schedule Y), to generate clear, concise and comprehendible CRFs, maintenance of safety databases, coding  of diseases, ADRS & medications, reconciliation of SAEs in accordance with specific guidelines, review trial protocol on a periodic basis, generation of PSURs etc.

Electronic Data Capture (EDC) in Clinical Trials

Categories: Clinical Data Management, Clinical Research  |   Comments(2)

Ever wondered how the data that is generated during a clinical trial is captured? The system used by most pharmaceuticals and CROs these days is called as an Electronic Data Capture or EDC as we know it. So what basically is an EDC? It is a computerized system which is specifically designed to collect data during clinical trials in an electronic format. This system replaces the traditionally used paper based system.

Medical Journalism in Clinical Research

Categories: Clinical Research, Medical Journalism  |   No Comments

In the recent past, many events have contributed in misleading the general public about the importance of clinical research. Most people tend to believe that clinical research just makes “guinea pigs” out of people with no importance or benefits to anyone in particular. The inaccuracies in both print and mass media along with speculations has highlighted the “ugly” side of clinical research, without actually informing the public of what exactly has gone wrong  and what measures are needed to rectify the problem.

Medical Writing Careers- Marketing and Scientific

Categories: Diploma Clinical Research & Medical Writing, Medical & Scientific Writing, Scientific Writing Courses  |   No Comments

Medical Writing is indeed a great career!! But many of us probably are unaware of the two aspects which constitute medical writing namely Marketing & Scientific Medical Writing. This article is an attempt to bring on the subtle differences between the two and make an individual choose between the best career suited to his/ her capabilities.

Medical Journalism

Categories: Medical Journalism  |   No Comments

Medical Journalism is a wonderful amalgamation of Literature, Science & Medicine. This uniqueness makes it a one of its kind career. Students undertaking a course in medical journalism will learn to apply particular skill sets to work as a practicing medical and science journalist in different sectors and media platforms. The main purpose of medical journalism is to bring forth the wonder of science and medicine in the minds of various readers, viewers & listeners all over the world. It can be thus said that medical journalists bridge the gap between the common man and the medical and scientific fraternity.